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Medical Device Glossary

Medical Device Manufacturing Terms and Medical Device Consulting Terms

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Business method

A collection of related, structured activities or tasks that produce a specific service or product for a particular customer.

Design for Manufacture and Assembly (DFMA)

To identify, quantify and eliminate waste or inefficiency in a product design. Also used as a tool to study competitors products, and as a good tool to insure the most robust and best cost design is achieved.

Die Cutting (shearing)

A process which cuts stock without the formation of chips or the use of burning or melting.

Injection Molding

A manufacturing process for producing parts from both thermoplastics and thermoset plastic materials. The raw plastic material is fed into a heated barrel, mixed, and forced into a mold cavity where it cools and hardens and is removed to the configurations of the cavity in the mold.

Injection Molding of Liquid Silicone Rubber (LSR)

a process to produce pliable, durable parts from liquid silicone thermoset materials in higher volumes.

Medical Liquid Silicone Rubber

A high purity platinum cured silicone, usually Class VI USP with low compression set, great stability and ability to resist extreme temperatures of heat and cold ideally suitable for production of part, where a high quality, inert material is a must. Some grades are approved for patient contact, long term implantation and short term implantation.

Medical Device

A product which is used for medical purposes in patients, to diagnosis, treat or cure a variety of conditions.

Medical Device Middle Market M&A

Refers to medical device OEM companies, contract manufacturers or other service providers with revenues generally between US $100 million and 1 Billion per year and the aspect of corporate strategy, finance and management dealing with the buying, selling, dividing and combining of different companies and similar entities than can aid, finance, or help an enterprise grow rapidly in its sector, location of origin, new field or new location without creating a subsidiary, other child entity or using a joint venture.

Mold or Die

Tooling used to produce plastic parts in molding.

Offshore Outsourcing

The practice of hiring an external organization to perform a "business method" in a country other than the one where the product(s) or service(s) are actually developed or manufactured.

Offshoring

The relocation by a company of a "business method" from one country to another - typically an operational process, e.g., manufacturing.

Operational Due Diligence (ODD)

The process by which a potential purchaser reviews the operational aspects of a target company during mergers and acquisitions.

Original Equipment Manufacturer (OEM)

Manufactures products or components that are purchased by a company and retailed under that purchasing company's brand name.

Outsourcing

The practice of contracting a "business method" (design, manufacturing, etc.) to a third party.

Over molding

Some molds allow previously molded parts to be reinserted to allow a new layer of a differing material to form around the first part.

Plastic Engineering

Encompasses the processing, design, development and manufacturing of plastic products.

Prototyping

An early sampling or model built to test a concept or to act as a model to be replicated in production quantities.

Shearing

See Die Cutting

Sourcing

Refers to a number of procurement practices, aimed at finding, evaluating and engaging suppliers of goods and services.

Strategic partnership

A formal alliance between two commercial enterprises, typically two companies each possessing one or more business assets that will help the other, but that each respective other does not wish to develop.

Thermoplastic

A polymer that turns to a liquid when heated and freezes to a very glassy state when sufficiently cooled, this process can be repeated over with all thermoplastics, as they may remelted and reformed.

Two Shot Injection Molding

Some molds are designed to "over mold" within a single molding cycle and must be processed on specialized injection machines. This process is actually an injection molding process performed twice. First, the base color material is molded into a basic shape, which contains space for the second shot. Then, the second material, or a different color, is injection-molded into those spaces and the parts are removed.